What is the Best Treatment for Spinal Stenosis? Who are the best in the world to treat spinal stenosis.
These are great questions.
I am not a back expert but a friend asked for some help on this issue so here is what I could find on the latest in treating spinal stenosis, a debilitating condition.
Check with your primary MD about any of the data below.
The key points are:
1. If you are having new, severe back pain that has changed in intensity, get a repeat MRI if not done in last 3 months.
2. Ask if you have: Epidural fibrosis (EF) which has a worse prognosis after surgery (see below).
3. Treatment depends on exactly what kind of spinal stenosis one has.
SC
4. Just because a surgeon has a lot of publications does not make him a good surgeon.
5. The only real way to know if the surgeon is good is to ask the nurses who do surgery with the surgeon or the scrub tech who does surgery with the surgeons in the hospital. Outcomes data is hard to come by aside from the study below done in Europe (that I could find in a quick literature search for the US). Patient testimonials, Yelp reviews, etc., all have their pluses & minuses.
It is thought that the better trained the surgeon is (ie, more prestigious preceptors, hospital, university), usually the better outcomes they will have but this has not been proven in a publication that I know of specifically. Also, in order to get named top surgeon in some lists, such as Castle Connelly, the surgeon has to pay to be included.
6. List of top surgeons in the area are below **
References:
1. This is a great review in general.
Surg Neurol Int. 2018; 9: 87.
Published online 2018 Apr 23. doi: 10.4103/sni.sni_66_18
PMCID: PMC5926215
PMID: 29740508
Case presentation and short perspective on management of foraminal/far lateral discs and stenosis
Copyright : © 2018 Surgical Neurology International
This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
INTRODUCTION
There are many techniques available for treating lumbar foraminal/far lateral disc (FOR/FLD) herniations with stenosis. The choice of surgical procedures must be based on each patient's preoperative dynamic X-ray, MR, and CT findings. Decompressive procedures may vary, and can include; laminotomy/laminectomy alone, the intertransverse approach (ITT), and Wiltse's far lateral technique. Where full unilateral facetectomy is warranted, patients may require noninstrumented vs. instrumented fusions (e.g., pedicle screws with posterolateral lumbar fusion (PLF), or rarely, transforaminal lumbar interbody fusion (TLIF)). No matter what operative approach is chose, adjunctive measures should include; continuous intraoperative physiological monitoring (e.g., somatosensory evoked potentials and electromyography), the use of an operating microscope, and an intraoperative radiograph with a marker within the disc space to confirm the correct level of disc removal.
MATERIALS AND METHODS
Symptoms and signs of foraminal/far lateral discs
The symptoms and signs for patients with lumbar FOR/FLD vary.[2,3,4,5,6] As these discs typically directly compress the dorsal root ganglion (DRG) of the superior/foraminally/far laterally exiting nerve root (e.g. within the axilla), these patients typically exhibit a superior unilateral radiculopathy. For example, at the L4-L5 level, the patient may demonstrate a predominant L4 root syndrome. Additional pathology may include; stenosis, ossification of the yellow ligament (OYL), and synovial cysts. These degenerative changes may further contribute to thecal sac and inferior L5 root compression at the index level (e.g., L4-L5).
Evaluation of FOR/FLD with dynamic X-rays, MR, and CT studies
Dynamic X-rays, MR, and CT studies contribute to the correct diagnosis, localization, and management of lumbar FOR/FLD and attendant stenosis.[2,3,4,5,6] Dynamic X-rays document whether there is active motion at the level of the FOR/FLD. If there is instability, additional noninstrumented vs. instrumented fusion may be warranted. On axial MR studies, typically localized to the disc spaces, FOR/FLD extending to the mid-vertebral level may be under diagnosed or missed. Here, careful evaluation of the parasagittal MR images may better demonstrate FOR/FLD extension (e.g. laterally/foraminally, and inferiorly). However, CT studies, with contiguous axial 2 mm cuts, may more readily pick up the full extent of FOR/FLD, while also documenting the presence of accompanying limbus vertebral fractures. Further, MR and CT studies combined should better confirm the extent of stenosis, OYL, and/or the presence of accompanying synovial cysts.
History of decompressive surgery for lumbar FOR/FLD
FLD: Wiltse far lateral approach to lumbar FLD
Wiltse and Spencer in 1988 described a purely far lateral approach to lumbar disc herniations [Table 1].[10] This procedure involved dissection/exposure focused lateral to the canal, and the facet joint. The Wiltse procedure became known for: “Specifically, its use for removing a far lateral disc, decompressing a far out syndrome, (and) inserting pedicle screws…” In some cases, it also required resection of the lateral one-third of the facet joint to attain more extensive exposure of the lateral foramen. Taking down the intertransverse ligament and fascia, the Wiltse approach offered far lateral exposure of the cephalad/foraminally/far laterally exiting nerve root, but no access to the medial spinal canal and/or proximal or mid portion of the neural foramen. Therefore, in the presence of significant stenosis or other spondyloarthrotic pathology within the spinal canal and proximal/mid foramen, this approach will typically not suffice.
Table 1
Decompressions for 170 Lumbar FOR/FLD
In 1995, Epstein initially evaluated the surgical procedure/outcomes for 170 MR/CT confirmed FOR/FLD (1984–1994) [Table 1].[2] These patients were managed with three different decompressive operative approaches: complete facetectomy (n = 73), laminotomy with medial facetectomy (n = 39 patients), and intertransverse discectomy (ITT: Intertransverse Approach) (n = 58 patients). Patients were followed on an average of 5 years. Of interest, outcomes were comparable for all three groups; good/excellent results were obtained in 79% intertransverse approach (ITT), 70% facetectomy group vs. 68% laminectomy/laminotomy. Therefore, the optimal lumbar FOR/FLD decompressive procedure should offer the best exposure for that specific patient, irrespective of the need for more extensive facet resection. Of interest, outcomes across all groups were comparable with very rare requirements for fusion.
SF-36 outcome study for FOR/FLD lumbar discs
In 1997, Epstein and Hood utilized the Medical Outcome Trust's SF-36 Short Form to assess outcomes for 76 (45% of the original sample of 170 patients) patients undergoing the three different operative approaches enumerated above for lumbar FOR/FLD (1984 and 1994) [Table 1].[3] Patients averaged 60.1 years of age. SF-36 evaluations were obtained an average of 9.1 months (direct assessment), and 2.8 years postoperatively (phone interviews). Outcomes were excellent (n= 32), good (n = 24), fair (n = 12), and poor (n = 8). As outcomes were comparable for all three procedures, this patient-based outcome study confirmed that the decompression chosen for any patient with a lumbar FOR/FLD should best be tailored to their specific requirements, irrespective of the extent of facet resection.
2007: Minimally invasive endoscopic discectomy/FOR/FLD; increased morbidity
In 2007, Sasani et al. evaluated the safety/efficacy of percutaneous minimally invasive (MI) endoscopic discectomy for FOR/FLD in 66 patients (1998–2005) [Table 1].[8] They determined from the literature that FOR/FLD constituted 11% of all lumbar disc herniations. Discs were respectively located at: L4-5 (n = 42; 64%), L3-4 (n = 19, 28%), and the L2-3 levels (n = 5, 8%). Patients were followed for 6–12 postoperative months. There were nine complications. For two patients (n = 1, L4-5 and n = 1, L4), the FLD could not be accessed using this technique; rather, diskectomy with microscopic visualization was required (e.g. secondary surgery). Three (n = 3, L4-5) patients required additional operations 3-6 months later. Furthermore, 2 patients (n = 2, L4-5) sustained partial nerve root injuries attributed to operative dissection, and another 2 patients (n = 2, L4-5) sustained neural injuries due to malpositioning of the working channel itself. At six postoperative months, the authors found all patients had improved, but voiced the following concerns: “Percutaneous endoscopic discectomy is a minimally invasive method and offers many benefits to the patient, but extensive surgical practice is needed to become a capable surgeon.” Notably, the total morbidity for this MI endoscopic approach was 13.6% (9 patients) of the 66 cases. These data should prompt one to ask whether the time has not come for MI endoscopic surgery for lumbar FOR/FLD.
2012: Three different minimally invasive decompressions for FOR/FLD
Liu et al. (2012) documented comparable results for three different MI procedures addressing 52 (2000–2006) FLD [Table 1].[7] They noted FLD comprised 2.6–11.7% of all lumbar disc herniations. Procedures included MI endoscopic discectomy (n = 25), METRx discectomy (n = 13), and X-tube discectomy (n = 14). Patients were followed or a mean of 13.5 months. Postoperatively, excellent outcomes were seen in 84.0, 84.6, and 92.8% patients respectively. Visual analog scale (VAS) scores were also comparable across all three groups. Note in this study, the number of patientsin each operative group was relatively small. Therefore, any conclusions regarding the safety of these minimally invasive procedure, based on this study, are of limited value.
2014: Extraforaminal intertransverse (ITT) approach to lumbar FLD (far lateral lumbar disc herniation)
In 2014, Celikoglu et al. evaluated the extraforaminal surgical management of 33 far lateral lumbar discs utilizing an intertransverse approach (ITT) (e.g. with median or paramedian incisions) (2006–2011) [Table 1].[1] Patients averaged 51.2 years of age, and had surgery at L3-4 (12 patients) or L4-5 (15 patients) utilizing median paramuscular (20 patients, 61%) or paramedian intermuscular (13 patients, 39%) approaches. With MacNab's criteria, the outcomes were graded as excellent/good (29), and fair/poor (n = 4). They concluded the ITT procedure for far lateral lumbar disc herniations was a safe and effective surgical alternative that avoided spinal instability. Furthermore, it was preferable to a laminectomy with medial or total facetectomy. Hypothetically, the ITT approach sounds ideal. However, it limits visualization and may increase the risk of injury to the mid-foraminal portion of the cephalad foraminally and far laterally exiting nerve root. Furthermore, it typically requires more extensive facet resection both medialy and far laterally, leaving the intervening facet weakened and subject to facture.
Efficacy of laminectomy alone for excision of FOR/FLDs
Over two postoperative years, Epstein (2017) observed low complication and reoperation rates for 58 patients undergoing 2-3 level and 79 patients undergoing 4-6 level lumbar laminectomies without fusions, including those with FOR/FLD [Table 1].[6] The 2-3 level procedures addressed; 20 synovial cysts, 1 degenerative spondylolistheesis (DS), and 48 herniated discs. Twelve of the 48 discs were FOR/FLD discs involving the L2-3 (n = 1), L3-4 (n = 1), L4-5 (n = 6), and L5-S1 (n = 4) levels. The 4-6 level operations additionally addressed; 35 synovial cysts, 26 with DS, and 39 lumbar discs. Sixteen of 39 were FOR/FLD discs located at the L2-3 (n = 1), L3-4 (n = 2), L4-5 (n = 10), L5-S1 (n = 3) levels. Of interest, no patient in either series developed a new neurological deficit. Furthermore, there were no infections, and none warranted readmission. Only one patient in the 4-6 level laminectomy group required secondary surgery (e.g., 7 days postoperatively for a seroma). Notably, atlhough a total of 28 (20.4%) of 137 patients with lumbar stenosis additionally had FOR/FLD, none developed postoperative lumbar instability requiring a fusion.
CASE REPORT
A patient with a history of low back pain, presented with 10 days of severe left lower extremity numbness, tingling, and weakness. The dynamic X-rays, MR, and CT studies demonstrated moderate stenosis/OYL L2-L5, bilateral synovial cysts at L4-L5, a left L3-L4 synovial cyst, and a massive left L3-L4 FOR/FLD with limbus fracture. The FOR/FLD disc herniation extended all the way to the L2-L3 level (e.g. markedly compressing the axilla of the L3 root) [Figures [Figures11–4]. Surgery required an L2-L5 laminectomy, resection of bilateral L4-L5, and the left L3-L4 synovial cysts, plus resection of a massive left L3-L4 FOR/FLD with limbus fracture using the down-biting curette/mallet technique. Utilizing the operating microscope and the undercutting technique, allowed for preservation of the facet joints and stability. The operating microscope and intraoperative monitoring helped avoid neural injury. At surgery, an intraoperative lateral X-ray clearly documented a Penfield elevator correctly located within the L3-L4 disc space (e.g. this is used to avoid wrong-level diskectomy) [Figure 5]. Postoperatively, the patient was neurologically intact, and never demonstrated instability.
Noninstrumented and instrumented fusion alternatives for lumbar FOR/FLD
Lumbar laminectomy with in situ fusion for stenosis and including FOR/FLD
In 2017, 59 patients underwent multilevel laminectomies (average 4.0 levels) and noninstrumented fusions (average 1.2 level) [Table 1].[5] Epstein documented high noninstrumented fusion rates utilizing lamina autograft and Nanoss (RTI Surgical Alachua, FL, and USA) combined with autogenous bone marrow aspirate [Table 1].[5] Prior to surgery, patients exhibited OYL/stenosis, DS (n = 51), spondylolysis (n = 2), synovial cysts (n = 32), and disc herniations (n = 21). Ten of the 21 discs were FOR/FLD: L2-3 (n = 1), L3-4 (n = 2), L4-5 (n = 6), L5-S1 (n= 1). Postoperatively, patients were followed an average of 3.1 years. The X-ray/CT studies documented a 97% postoperative fusion rate occurring an average of 4.9 months postoperatively (57 of 59 patients). Two patients with severe osteoporosis, morbid obesity, and smoking histories had pseudarthroses that were not sufficiently symptomatic to warrant additional surgery.
Decompression with instrumented fusion for far lateral lumbar discs
A unilateral full facetectomy may be required for excision of FOR/FLD, particularly when combined with severe spondyloarthrosis, DS, and/or spondylolisthesis/lysis. Here, a full facetectomy provides excellent visualization of the entire course of the cephalad, foraminally, and far laterally exiting nerve root along with the ipsilateral thecal sac and inferiorly exiting nerve root. In these cases, patients may require a posterolateral fusion (PLF) utilizing pedicle/screw instrumentation, or in select cases, a TLIF. Nevertheless, the addition of an interbody device may require increased manipulation of the thecal sac and/or nerve roots increasing perioperative morbidity (e.g., neruological root deficits, increased cerebrospinal fluid leak, etc.).
2016 Dorsal root ganglion (DRG) injury for MI TLIF for FLD
In 2016, Wang et al. observed that 5 (0.9%) of 539 patients exhibited postoperative dysesthesias (POD) attributed to DRG injury following MI TLIF (2010–2014) [Table 1].[9] One of these five cases involved a complication attributed to a FLD; in toto, this meant there was 1 (3%) complication out of a total 34 patients with FLD. Here, the exposure provided by the MI TLIF may not have afforded adequate visualization of the cephalad foraminally/far laterally exiting nerve root, making it more susceptible to injury. Of interest, the remaining four injuries were due to: 1 recurrent lumbar disc herniation (1/36 recurrent discs; 3%), and 3 instances of DS (3 out of 201 with DS; 1%).
DISCUSSION
There are multiple alternative operative approaches for the management of lumbar FOR/FLD with stenosis. Preoperative assessment requires dynamic X-rays, MR, and CT studies to document the full extent/location of the FOR/FLD and accompanying stenosis and other degenerative pathology. When performing a medial intracanalicular decompression, one should utilize the operative microscope and the undercutting technique to preserve the lateral 2/3 of the facet joint, and maintain stability. Further, the extent of facet resection should be minimized by utilizing the operative microscope. The use of intraoperative monitoring should help avoid neural injury. Performing any one of the various MI techniques (e.g., endoscopic discectomy or MI TLIF) may unnecessarily add morbidity (e.g., root injury, retained disc, residual stenosis). Finally, no matter what the operative approach, it is critical to obtain an intraoperative lateral radiograph with an instrument in the correct disc space to avoid wrong level surgery.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Footnotes
REFERENCES
1. Celikoglu E, Kiraz I, Is M, Cecen A, Ramazanoǧlu A. The surgical treatment of far lateral lumbar disc herniation: 33 cases. Acta Orthop Belg. 2014;80:468–76. [PubMed]
2. Epstein NE. Evaluation of varied surgical approaches used in the management of 170 far-lateral lumbar disc herniations: Indications and results. J Neurosurg. 1995;83:648–56. [PubMed]
3. Epstein NE, Hood DC. A comparison of surgeon's assessment to patient's self analysis (short form 36) after far lateral lumbar disc surgery.An outcome study. Spine (Phila Pa 1976) 1997;22:2422–8. [PubMed]
4. Epstein NE, Hollingsworth RD. Nursing review section of Surgical Neurology International: Part 1 lumbar disc disease. Surg Neurol Int. 2017;8:301. [PMC free article] [PubMed]
5. Epstein NE. High lumbar noninstrumented fusion rates using lamina autograft and Nanoss/bone marrow aspirate. Surg Neurol Int. 2017;8:153. [PMC free article] [PubMed]
6. Epstein NE. Tisseel's impact on hemostasis for 2-3 and 4-6-level lumbar laminectomies. Surg Neurol Int. 2017;8:299. [PMC free article] [PubMed]
7. Liu T, Zhou Y, Wang J, Chu TW, Li CQ, Zhang ZF, et al. Clinical efficacy of three different minimally invasive procedures for far lateral lumbar disc herniation. Chin Med J (Engl) 2012;125:1082–8. [PubMed]
8. Sasani M, Ozer AF, Oktenoglu T, Canbulat N, Sarioglu AC. Percutaneous endoscopic discectomy for far lateral lumbar disc herniations: Prospective study and outcome of 66 patients. Minim Invasive Neurosurg. 2007;50:91–7. [PubMed]
9. Wang H, Zhou Y, Zhang Z. Postoperative dysesthesia in minimally invasive transforaminal lumbar interbody fusion: A report of five cases. Eur Spine J. 2016;25:1595–600. [PubMed]
10. Wiltse LL, Spencer CW. New uses and refinements of the paraspinal approach to the lumbar spine. Spine (Phila Pa 1976) 1988;13:696–706. [PubMed]
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2.
Spine J. 2018 May 21. pii: S1529-9430(18)30253-5. doi: 10.1016/j.spinee.2018.05.028. [Epub ahead of print]
Lumbar spinal stenosis: comparison of surgical practice variation and clinical outcome in three national spine registries.
Lønne G1, Fritzell P2, Hägg O3, Nordvall D4, Gerdhem P5, Lagerbäck T5, Andersen M6, Eiskjaer S7, Gehrchen M8, Jacobs W9, van Hooff ML10, Solberg TK11.
Author information
- 1
- Department of Orthopaedics, Innlandet Hospital Trust, Lillehammer, Norway; National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Norway. Electronic address: gloenne@mac.com.
- 2
- Department of Orthopaedics, Capio St Göran Hospital, Stockholm, Sweden; Department of Surgical Sciences, Division of Orthopaedics, Uppsala University, Sweden; Strömstad akademi, Strömstad, Sweden; Qulturum Center for Learning and Innovation in Healthcare, Jönköping, Sweden.
- 3
- Spine Center Göteborg, Göteborg, Sweden; Swespine Steering Group, Swedish National Spine Register, Jönköping, Sweden.
- 4
- Qulturum Center for Learning and Innovation in Healthcare, Jönköping, Sweden.
- 5
- Department of Orthopaedics, Karolinska University Hospital Huddinge, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
- 6
- Sector for Spine Surgery and Research, Lillebaelt Hospital, Middelfart, Denmark.
- 7
- Department of Orthopedic Surgery, Aalborg University Hospital, Aalborg, Denmark.
- 8
- Spine Unit, Department of Orthopaedic Surgery, Rigshospitalet University of Copenhagen, Denmark.
- 9
- The Health Scientist, The Hague, The Netherlands.
- 10
- Department Research, Sint Maartenskliniek, Nijmegen, The Netherlands; Department of Orthopedics, Radboud university medical center, Nijmegen, The Netherlands.
- 11
- The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Norway; Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway; Institute of Clinical Medicine, University of Tromsø The Arctic University of Norway, Tromsø, Norway.
Abstract
BACKGROUND:
Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation.
PURPOSE:
To evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness.
STUDY DESIGN:
An observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark.
PATIENT SAMPLE:
Patients aged 50 and higher operated 2011-2013 for LSS were included.
OUTCOME MEASURES:
Patient-reported outcome measures (PROMs) Oswestry disability index (ODI) (primary outcome), numeric rating scale (NRS) for leg pain and back pain, and health-related quality of life (EQ-5D). Analysis included case-mix adjustment. In addition, we report differences in hospital stay.
METHODS:
Analyses of baseline data were done by analysis of variance (ANOVA), Chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at one-year follow-up between the countries were done by ANOVA (crude) and analyses of covariance (ANCOVA, case mix adjustment). There are no conflicts of interest. Funding was received from the Danish Society of Spinal Surgery ($5,925), the Northern Norway Regional Health Authority ($5,925) and from Swedish Association of Local Authorities and Regions ($11,885). The sponsor had no role in the acquisition of data, analysis, or preparation of the manuscript.
RESULTS:
Out of 14,223 included patients, 10,890 (77%) responded at one-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without, with spondylolisthesis) was: Norway 11% (4%, 47%), Sweden 21% (9%, 56%) and Denmark 28% (15%, 88%). At one-year follow-up the mean improvement for ODI (95%CI) was: Norway 18 (17 to 18), Sweden 17 (17 to 18), and Denmark 18 (17 to 19). Patients operated with arthrodesis had prolonged hospital stay.
CONCLUSIONS:
Real life data from three national spine registers showed similar indications for decompression surgery, but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.
Introduction
Low back pain is the leading specific cause for years lived with disability worldwide [1]. Narrowing of the spinal canal, known as lumbar spinal stenosis (LSS) is the most common indication for spine surgery in the elderly population. LSS typically causes symptoms of low back pain, lower extremity pain and numbness due to nerve root compression, resulting in walking disability [2]. Decompression of the spinal canal is the key objective of surgery and is considered superior to non-surgical treatment for patients with moderate to severe LSS [3]. Often, there is a coexisting degenerative spondylolisthesis, i.e. a slip of one vertebra in relation to another. Traditionally, this radiological finding has been regarded as a sign of segmental instability. Although this interpretation has been disputed, adding surgical fusion between the two vertebrae (arthrodesis) in addition to decompression has been recommended to prevent persisting back pain 4 ; 5. However, several recent studies found no effect of additional arthrodesis surgery 6; 7 ; 8. Due to lack of uniform guidelines in this field, there is a large and possibly unwarranted practice variation in the use of additional arthrodesis 9 ; 10. In a recent study fusion rate (with, without spondylolisthesis) was considerably lower in university hospitals of Norway (44%, 6%) compare to Boston, US (95%, 29%) [11]. In the US, rising costs connected to arthrodesis of the lumbar spine have attracted the attention of health providers and policy makers. In 2011 spinal fusion accounted for the highest aggregate hospital costs of any surgical procedure performed in U.S. hospitals ($12.8 billion) [12].
The higher cost connected to arthrodesis surgery should be justified by better patient-reported outcome. In 2015, the International consortium for health outcome measurement (ICHOM) recommended a set of patient-reported outcome measures (PROMs) for evaluating surgical treatment of degenerative conditions in the lumbar spine to facilitate clinical studies across nations and centers [13]. The national spine surgery registries of Norway, Sweden, and Denmark were among the collaborators. Scandinavian countries are characterized by a genetically homogenous population, similar social security systems, and public based health care and health insurance systems, facilitating comparative studies [14]. The incidence of surgically treated lumbar spinal stenosis is similar (30-35/100 000/year) based on imputed numbers from the registries. Clinical registries collecting data from everyday practice can evaluate different treatment strategies by linking practice-based variation to patient-reported outcomes in a pragmatic trail. Unlike randomized controlled trials, registry-based studies allow for surgeons and patients preferences to be included in the process prior to surgery, as in the “real world” of clinical practice, and adds external validity to already published data from randomized controlled trails [15]. Such information may aid in guideline development and resource allocation.
The aims of this observational multinational register study were to compare practice-based variation in surgical treatment of LSS by; (1) surgical selection criteria (preoperative patient characteristics), (2) type of surgery (decompression only or decompression plus arthrodesis), and (3) to assess if practice-based variations were associated to different patient-reported outcomes (crude and case mix adjusted), in a large combined registry cohort from three Scandinavian countries.
Methods
This observational study reviews data from the national spine registries of Norway (NORspine), Sweden (Swespine), and Denmark (DaneSpine). Eligible patients were aged 50 or older with no history of previous lumbar spine surgery, operated for LSS during 2011, 2012, or 2013. At baseline, the surgeon recorded diagnosis and treatment according to standardized questionnaire. The diagnosis of LSS was based on the surgeons' clinical judgment and assessment of magnetic resonance imaging, MRI. Concomitant spondylolisthesis is defined as a visible slip, 3 mm or more, of one vertebra in relation to another. All patients received surgical decompression, some with concomitant arthrodesis.
The registers
All three national spine registries are designed for quality control and research. The participation is voluntary for the surgical departments as well as the patient. At admission for surgery (baseline), the patient reports data on demographics, risk factors, and PROMs. During the hospital stay, the surgeon records diagnosis, type of surgery, and perioperative complications. At one-year follow-up, questionnaires are distributed from the central national registry office, completed at home by the patients, and returned in pre-stamped envelopes. The treating hospitals are not involved in follow up. The oldest registry, Swespine, has included patients since 1998. Swespine covers approximately 95% of the surgical units in Sweden. Completeness, the proportion of operated patients reported to Swespine, was approximately 75%. NORspine is based on the concept of Swespine, and was founded in 2007 (coverage 95%, completeness of 65%). DaneSpine was acquired by the Danish Spine Society from the Swedish Society of Spinal Surgeons in 2009 and has successively been implemented (coverage 80%, completeness 62%).
Patient-reported outcome measures (PROMs)
We used the ICHOM recommended set of PROMs [13]. The primary outcome was the Oswestry Disability Index (ODI, version 2.1), a standard for measuring back pain related disability, ranging from 0 (no disability) to 100 (bedridden) [16].
Secondary outcome measures were numeric rating scales (NRS) for back and leg pain, ranging from 0 (no pain) to 10 (worst conceivable pain). Health-related quality of life was measured with the Euro-Qol-5D (EQ-5D) ranging from -0.596 to 1, with higher scores indicating better quality of life.
NORspine used the NRS for leg and back pain, while Swespine and DaneSpine used the Visual Analogue Scale (VAS), ranging from 0-100. Conversion to NRS was done by dividing the VAS score by ten with a stochastic approximation of decimals to the closest integer.
Discussion
To our knowledge, this represents the worlds' largest observational study of patients operated for LSS, and the first comparison across countries using the ICHOM-recommended core data set. Even though the selection criteria for surgery in terms of demographic characteristics, pain intensity and disability were similar, we found a significant practice variation, i.e. use of additional arthrodesis surgery was almost three times higher in Denmark and two times higher in Sweden as compared to Norway (Figure 2). This demonstrates that even in homogenous populations with similar health care systems the treatment traditions can vary considerably. We observed longer hospital stay among patients operated with additional arthrodesis, which, together with the implants used, indicates higher cost but no better treatment effectiveness.
Our findings are in accordance with a recent Swedish randomized controlled trial (RCT) by Försth et al. of 247 patients showing that additional arthrodesis neither reduced reoperation rates nor improved clinical outcomes (ODI) [6]. A randomized controlled trial from the US by Ghogawala et al. involving 66 patients found that additional arthrodesis surgery for LSS with mild spondylolisthesis reduced the risk for reoperation and gave larger improvement of physical health–related quality of life (generic SF 36) than laminectomy alone [7]. For all other outcomes, including the disease specific ODI, no difference was found. This study has been heavily criticized, also because reoperation rate during follow-up was remarkably high [21]. Higher frequency of reoperations in the US may however reflect potential cultural differences in patient expectations, difference in treatment traditions and incentives for arthrodesis surgery driven by health insurance and reimbursement programs compare to those found in countries like Sweden.
A Swedish non-randomized registry study of 5390 LSS patients with or without spondylolisthesis operated between 1998 and 2008, found no benefit of additional arthrodesis after two years [8]. Similar results were shown in a Swiss multicenter study from 2017 of 185 patients with LSS and spondylolisthesis after three years [22]. A recent Norwegian pragmatic comparative effectiveness study showed marginally better improvement (less than MCIC), of back pain among LSS patients with spondylolisthesis receiving decompression plus arthrodesis. No such association was found for ODI [23].
We also found a large difference in the use of additional arthrodesis in patients without spondylolisthesis in 2011 – 2013. This treatment strategy has been discussed among spinal surgeons for many years, and is not in accordance with guidelines from 2013, where “decompression alone is suggested for patients with leg predominant symptoms without instability” 2; 4 ; 9. The term “instability” is poorly defined, but has been linked to low back pain, a frequent symptom in LSS. This may explain the practice variation, also shown in a previous study where the arthrodesis rate in cases without spondylolisthesis was 29% in Boston (US), compared to only 6% in Norway [11]. We observed a rising rate of arthrodesis from Norway, via Sweden, to Denmark across the countries (Figure 2), but no corresponding trend (dose-response effect) in terms of higher treatment effectiveness (Table 3). In fact, the mean improvement of back pain in the spondylolisthesis group was somewhat higher in Norway (3.6) than in Denmark (2.7), which had the highest rate of arthrodesis (Figure 3). Hence, this study does not support the argument that arthrodesis prevents low back pain related to instability in spinal stenosis patients. The different frequency of multiple level surgery was small, and can neither explain the difference in the fusion rate, nor the lack of difference in outcome.
We did both crude analysis and case mix analysis. Crude data shows small, not clinical relevant difference in the outcome between those with spondylolisthesis having decompression and fusion, but these differences vanished after the case mix adjustment (Table 4).
Fox et al. concluded in 1996 that radiological instability was common after decompression for degenerative LSS without spondylolisthesis, but correlated poorly with clinical outcome (back pain) [24]. The quality of some earlier studies advocating additional arthrodesis routinely is low due to small sample sizes, weak design, and outcome based on radiological findings [25]. Moreover, a change towards using more minimally invasive decompression techniques may have reduced the risk for postoperative instability [26]. Previous studies show that arthrodesis adds higher risk of major complications, and even mortality [27]. Like Ghogawala et al., we found no association between the use of concomitant arthrodesis and surgeon reported complications [7].
Comorbidity rate in NORspine was physician-reported and higher compared to the patient-reported rate in Swespine and DaneSpine. However, outcomes were similar, also when adjusting for comorbidity (Table 3). Between countries with larger diversity in demographic, socio-economic and cultural features, case mix adjustment may be more important.
Even if the differences in effects sizes were smaller than considered as clinically relevant, subgroups of patients may benefit from additional arthrodesis. This should be investigated further in studies utilizing more precise data on radiological findings and with long term follow-up to assess reoperation rates.
Quality assurance
Loss to follow-up may bias the results. Two Scandinavian studies found that a loss to follow-up of as high as 23% would not bias conclusions about overall treatment effects 28 ; 29. They found, similar to our results, that non-responders were younger and more likely smokers. Therefore, it would be reasonable to assume that loss to follow up did not bias our results.
Strength and limitations
Register-based studies in general have advantages such as large sample sizes and high external validity, but also limitations due to lack of randomization, lower follow-up rates, and lower internal validity compared to closely monitored clinical trials. In contrast to RCTs, this study allows surgeons and patients preferences to be included in a shared decision-making process prior to surgery, like in the “real world” of clinical practice. Still, there is increasing evidence in the literature that observational studies, conducted according to STROBE check list, report corresponding results similar to those found in RCTs [30].
There are limitations associated with this work. Even though registry data were collected prospectively for quality control and research, the hypotheses were decided on in retrospect. In addition, we did not have exact data on reoperation rates and only one-year follow-up. Reoperation rates may be as high as 20% at long term (3 to 5 years) [6], but previous studies have shown that clinical outcomes are stable up to 5 years [6].
“In Scandinavia it is recommended to try conservative treatment prior to surgery for lumbar spinal stenosis. Previous studies show that the content of non-operative care is hard to define [31], and the effects of different conservative treatment alternatives are ambiguous. Since no uniform Scandinavian guidelines for such treatment exist, the type of preoperative conservative treatment was not recorded in the registries, only duration of symptoms.
The use of the ICHOM concept and adding case mix analyses makes comparisons more credible, but a relative small set of baseline variables has been used for case mix adjustment.
Conclusion
Real life data from three national spine registers showed similar indications for decompression surgery, but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.
Acknowledgement
The authors thank all the patients and surgeons contributing with data to the spine registers in Sweden, Denmark and Norway.
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